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TREATMENT ACCESS

FDA approval of generic ARVs: first atazanavir approval

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Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.

Date	Drug	Company
4 February 2008	Atazanavir (100, 150, 200mg)	Emcure, India
14 February 2008	AZT (300mg)	Matrix, India
29 February 2008	efavirenz (600mg)	Hetero, India
29 February 2008	d4T (15, 20, 30, 40mg)	Hetero, India
29 January 2008	3TC (300 & 150 mg)	Hetero, India

“Tentative Approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.

Effective patent dates are listed in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book
http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=3D021360&TABLE1=3DOB_Rx

comment

This brings the total of FDA approved generic drugs and formulations to 54 since the programme started. An updated list of generic tentative approvals

This is the first approval atazanavir, and the first approval of a protease inhibitor. Tenofovir was approved in November 2007, and the slow expansion to include second-line treatment options under this programme is clearly essential.

Source: FDA list serve
http://www.fda.gov/oashi/aids/listserve/archive.html

An archive of past list serve announcements is available on the FDA web site:
http://www.fda.gov/oashi/aids/listserve/archive.html

A list of FDA approved generic antiretroviral drugs for the treatment of HIV
http://www.fda.gov/oashi/aids/viralsgeneric.html

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